Meeting Date: Aug 5, 2009
Discussion topics included:
Questions to FDA from last meeting have not yet been discussed with FDA.
At the last SPL process team meeting, Lonnie Smith said that a new guidance document will be coming soon that will provide instructions/requirements for submitting final SPL to FDA once. Previous discussions have suggested the process would be that SPL would be sent to the Office of Compliance (OC), and referenced by the application.
What SPL filenames are being used in submissions to the review divisions? Filename must be the document GUID in the drug listing submission to OC, but there are no requirements for submission of spl to the review divisions. Concensus is that pharma/vendors are sending the same xml file (and same filename) to both OC and the review division. The review divisions have not sent back any comments objecting to using the GUID as the filename.
Import of API- Lonnie Smith stated that customs/import border officials are being trained on the new process drug listing process. How is API drug listing being managed in the electronic drug listing process. There are two scenarios.
US company has API manufactured by one of its foreign subsidiaries- eg in Ireland: The finished product needs to be drug listed electronically before product is shipped, and the foreign API supplier (name and DUNS number) must be included in the drug listing SPL.
Independent foreign manufacturers with multiple customers/importers: The foreign manufacturer would need to drug list the API themselves, using their own labeler code and NDC number. The customer/importer of API has 2 ways of managing the API. The preferred way is to list the foreign establishment (and their DUNS number) in the finished product SPL. If the foreign establishment is reluctant to acquire and/or provide the necessary information (ie its DUNS number) to the customer/importing company, then they can include the “Source NDC Product Code” in its drug listing SPL.
In both cases the foreign API manufacturer would need to have its establishment registered – ie be included in drug establishment registration SPL -- (Scenario 1)in the parent company’s drug establishment registration or (Scenario 2) submit its own drug establishment registration
Drug listing of export and export only products: There was a lot of discussion/question on this topic at previous teleconferences, however there has been no resolution. Jean and Gabriella worked on a letter to FDA summarizing key issues. Michael is working through how to best present this to FDA and have a discussion. The goal is to have the letter come from a pharma group, rather than a specific company. Drug listing of export only products will also be a session topic at the DIA meeting on August 11/12 – presenter will be David Mazyck of FDA. Michael will be at the DIA meeting and will report back to us.
Process for changing out JPG images as there are changes to carton/container labeling. The key questions related to how to best manage the image filenames and what images to include in the draft SPL. FDA review divisions are not using carton/container images in the SPL. So, the image names do not necessarily need to change in the SPL when the cartons/container labels change. However, this makes it difficult to manage the image files from a document life-cycle perspective. Ideas were exchanged by several participants for best practices. Key ideas included:
The filenames for cartons/container images should change when the labeling changes. This is a best practice for document lifecycle management.
If you modify the filenames change, the references to these images within the SPL also need to change to point to the right image/filename.
SPL best practices state that the GUID and effective time on each section should change when the content changes -- ie when the PDP section changes (text or images), the GUID and effective times for these sections should also change.
While SPL submitted to OC for drug listing must contain carton/container images, SPL submitted to the review divisions do not require these. In addition, companies may not have artwork for draft labeling. Thus, you should delete the images for the labels that are changing from the draft SPL that is being submitted to the review division.
What effective time should be used for draft SPL submissions to the review division? FDA is not validating the effective time, and you can use any 8 digit number for the date. Some companies are putting in future dates (eg 20250101). Another company is using 00000000.
Will there be a problem if an SPL with a future date is posted. If any SPL is posted or denoted as “current”, any SPL with a higher version number will supercede what has been used previously.
Discussion topics included:
- Will there be a problem if an SPL with a future date is posted. If any SPL is posted or denoted as “current”, any SPL with a higher version number will supercede what has been used previously.
Next Meeting Scheduled for Sept 2, 2009